10 GMP consultants

Experience: Independent GMP Compliance Consultant & Auditor · Genentech

Former Independent GMP Compliance Consultant & Auditor at Genentech (2022–2025), and Director, Audit & Inspection Readiness at Enterey Life Sciences Consulting since 2025. He was Assoc. Director (GxP), Corporate Global Compliance at BioMarin Pharmaceutical Inc. (2015–2022). His profile describes GMP compliance auditing and consulting that supports pharmaceutical drug testing, manufacturing, distribution and quality systems.

Experience: Owner and Principal · Campbell CGMP Services

Owner and Principal at Campbell CGMP Services since 2026; the profile describes the firm as a regulatory and compliance consulting company that helps global pharmaceutical teams navigate inspections, enforcement strategies and quality risk management. He was Senior Consultant at InterPro QRA (2012–2026) and Compliance Officer at the US Food and Drug Administration (2006–2011).

Experience: Senior Quality Consultant Life Science · GMP Advice

Senior Quality Consultant Life Science at GMP Advice since 2024; his profile headline lists GMP compliance, inspection readiness support, FDA inspections, audits, supplier and CMO management, validation and training. He was Head of Quality Management at Phyton Biotech (2000–2024) and QA Manager at Catalent (1992–1999).

Experience: President & Principal GMP Consultant · Pharma Consulting Group International (PCGI)

President & Principal GMP Consultant at Pharma Consulting Group International (PCGI) since 2019; his profile describes PCGI as a provider of quality and compliance consulting services and his work as helping life science companies achieve and sustain GMP compliance. He was Senior Vice President - Corporate Quality Compliance & Remediation at Wockhardt Ltd. (2018–2019) and Quality Head at Wockhardt USA (2020–2021).

Experience: President · MFM GMP Consulting

President of MFM GMP Consulting since 2016, where her profile headline lists her as Principal Auditor. She was Global QA Auditor at SGS (2014–2016) and Drug Specialist at FDA (2012–2014), and her profile describes a former FDA investigator who worked in the US and countries including China, India, Germany, Italy and Ireland.

Experience: President andSenior GMP Compliance Consultant for Healthcare Manufacturing · Globepharm Consulting

President andSenior GMP Compliance Consultant for Healthcare Manufacturing at Globepharm Consulting since 1984; other listed Globepharm roles cover GMP compliance consulting for worldwide governments and agencies and for legal testimony expert witness work. His profile lists facility design, technology transfer and helping clients pass FDA GMP inspections among his experience.

Experience: Owner and Principal Consultant · Kenformete Solutions, LLC

Owner and Principal Consultant at Kenformete Solutions, LLC and Lead Auditor, 503B Accreditation & GMP Compliance at the Coalition for Compounding Excellence, both since 2025. His profile says he provides quality and regulatory advisory services to pharma, biopharma and 503A/503B organizations, focusing on scalable cGMP systems and inspection readiness. He was Vice President, Quality and Compliance at Tris Pharma (2024–2025).

Experience: President Principal Consultant · RD NEAL LLC

President Principal Consultant at RD NEAL LLC since 2021; his profile describes FDA GMP compliance consulting as a regulatory CMC CGMP consultant with expertise in FDA requirements for GMP manufacturing of pharmaceutical products and medical devices. He was Senior Consultant at Biologics Consulting (2006–2021) and Senior Reviewer Consumer Safety Officer at U.S. Food and Drug Adminstration, CBER / OCBQ / DMPQ (1999–2006).

Experience: Principal Consultant · RWJ Consulting 4CGMP, LLC

Principal Consultant at RWJ Consulting 4CGMP, LLC since 2018; his profile says he works with several biotech firms on pre-approval inspection readiness, including gap identification and remediation, and cites a CAR T client with a successful FDA PLI result. He was Director GMP Compliance Auditing at GSK (2004–2014) and Field Investigator at FDA (1991–2004).

Experience: Senior Consultant, GMP SME · Exemplar Compliance

Former Senior Consultant, GMP SME at Exemplar Compliance (2015–2016), and President and Owner of Britt Pharma Consulting, LLC since 2013. He was also Senior Consultant at Tunnell Consulting, Inc. (2013–2014) and Director Quality Assurance at MicroDose Therapeutx (2009–2012). His profile describes building and maintaining quality systems and cGMP compliance remediation.